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Ecstasy3, 4- methlenedioxy - N -methamphetamine（Ecstasy）test kit (colloidal gold)

by Sanqi Biomedical(Shandong)Co., Ltd. China EUDAMED

Ref 5286Model 3Q-FA1000 EMDN W0102160502

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697447273004MF Basic UDI-DIDate3 Jun 2023RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference
3Q-FA1000, 5286
Primary DI / UDI-DI
06974472730045
Basic UDI-DI
697447273004MF
EMDN Code
W0102160502 Amphetamine/methamphetamine specific (+ecstasy) - rt & poc
Device Class
Class A
Market of Registration
France

Manufacturer details

EUDAMED SRN
CN-MF-000030641
Authorised representative
Lotus NL B.V. NL-AR-000000121

Other devices from Sanqi Biomedical(Shandong)Co., Ltd.

See all devices from Sanqi Biomedical(Shandong)Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Reagent
  • Professional Testing
  • Companion Diagnostics
Other properties (8)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED d1deb002-08dc-406f-b1ed-e17e53d1bfb3 61 fields · synced 24 Oct 2026